HeadachePhase 3NCT01939314
Sphenopalatine Nerve Block for Headache Tx360
A Phase 3 study testing Bupivacaine in people with Headache and Migraine, run by Indiana University at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the duration of the analgesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are 18 - 65 years of age
- present to emergency department (ED) triage with chief complaint of crescendo-onset anterior/frontal headache (affecting frontal, temporal, orbital, maxillary, and mandible region)
- have a normal neurological exams
Who cannot join
- are less than 18 years old or greater than 65
- have any focal neurological dysfunction signs or symptoms
- have a posterior/occipital/cervicogenic source predominance of headache
- are febrile (oral temperature 37.7 C or 100 F) or signs of acute or chronic sinusitis, such as congestion, has been present more than 10 days, there is a high fever, the nasal mucus is an abnormal color, or complains of face pain or headaches
- have self treated with pain medication or anti-emetic 4 hours prior to arrival
- have a history of peripheral vascular disease, cancer, or HIV infection
- are known to be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double-Blind Study Comparing the Efficacy of Sphenopalatine Nerve Block by Localized Mucosal Application of an Anesthetic vs Placebo for the Emergency Department Management
The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the duration of the analgesia.
- Being tested
- Bupivacaine, Placebo
- Keywords
- Headache, Migraine
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion
PlaceboDrug
Also called Normal Saline
Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | Bupivicaine .03ml to each nare Receives: Drug: Bupivacaine |
| Normal Saline | Placebo comparator | normal saline .03 ml to each nare Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale
Measured: 15 minutes from dose
Secondary outcomes (2)
Categorical Pain Relief
Categorical Pain Relief at 15 minutes. Participants were asked to categorize their pain relief at 15 minutes as "No", "Little", "Some", "A Lot" or "Complete". The table displays the number of participants who identified their pain relief in the categories provided.
Measured: 15 minutes from dose
Headache Free at 24 Hours
The percentage of patients that were headache free at 24 hours by follow-up phone conversation.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Schaffer, Indiana University
- Investigators
- Jason T Schaffer, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939314
- Sponsor's protocol ID
- TX 360 HA -Schaffer
- Other IDs
- Tian Medical Inc.
- Status last verified
- Jul 2015
- First submitted
- 3 Sep 2013
- Last updated
- 27 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind Study Comparing the Efficacy of Sphenopalatine Nerve Block by Localized Mucosal Application of an Anesthetic vs Placebo for the Emergency Department Management
- ClinicalTrials.gov ID
- NCT01939314
- Acronym / sponsor ID
- TX 360 HA -Schaffer
- Keywords
- Headache, Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Posted 27 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the duration of the analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: BupivacaineBupivicaine .03ml to each nare |
| Normal Saline | Placebo comparator | Drug: Placebonormal saline .03 ml to each nare |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- are 18 - 65 years of age
- present to emergency department (ED) triage with chief complaint of crescendo-onset anterior/frontal headache (affecting frontal, temporal, orbital, maxillary, and mandible region)
- have a normal neurological exams
Key exclusion criteria (7 listed)
- are less than 18 years old or greater than 65
- have any focal neurological dysfunction signs or symptoms
- have a posterior/occipital/cervicogenic source predominance of headache
- are febrile (oral temperature 37.7 C or 100 F) or signs of acute or chronic sinusitis, such as congestion, has been present more than 10 days, there is a high fever, the nasal mucus is an abnormal color, or complains of face pain or headaches
- have self treated with pain medication or anti-emetic 4 hours prior to arrival
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineBupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion | Drug | Bupivacaine |
| PlaceboAlso: Normal SalineNormal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion | Drug | Normal Saline |
Primary outcome
Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale
Time frame: 15 minutes from dose
2 secondary outcomes
Categorical Pain Relief
Time frame: 15 minutes from dose
Headache Free at 24 Hours
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Headache
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruiting
Acceptance and Commitment Therapy-Based Group Psychotherapy for Chronic Headache
Chronic Headache
Active, not recruiting
The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache
Cervicogenic Headache
Active, not recruitingObservational study
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
Migraine
Active, not recruitingObservational study
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Migraine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason T Schaffer, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine in people with Headache and Migraine, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale (time frame: 15 minutes from dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2015.